Kornimate/medical-research-clean huggingface dataset:
moms@home: a storytelling-based mobile health intervention to improve blood pressure management in pregnancy

Conditions: Hypertension in Pregnancy; Chronic Hypertension; Gestational Hypertension

Summary: this pilot study will examine the effects of a digital health approach, moms@home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.

the study aims to standardize and test a storytelling approach to promote hbpm and improve bp management and pregnancy-specific outcomes in pregnant women with hypertension (htn). the study will integrate three components to improve bp care and outcomes: 1) the moms@home mobile app to promote hbpm through storytelling videos and a patient dashboard of bp data, 2) a digital bp monitor for hbpm, and 3) an hbpm report that curates and shares key health data with the right provider at the right time. designed by and for pregnant women with htn across racial/ethnic groups, the moms@home intervention is novel because it leverages digital health, behavior change techniques, and culturally relevant storytelling to improve htn self-care while facilitating patient/caregiver communication through an hbpm report. investigators are conducting a pilot randomized controlled trial (rct) of moms@home vs. enhanced standard care, with plans to enroll 100 pregnant women (50% from racial/ethnic minority groups) with gestational or chronic htn to determine whether moms@home vs. enhanced standard care (bp monitor, diary) improves hbpm adherence (primary outcome) and to evaluate the feasibility, acceptability, and sustainability of the intervention.

Eligibility criteria:
inclusion criteria: * age 18-50 * english or spanish speaking * a diagnosis of gestational (20-26 weeks gestational age) or chronic hypertension (8-26 weeks gestational age) * singleton or multiple gestation pregnancy, * a patient of the university of massachusetts memorial health obstetrics/maternal and fetal medicine clinics in worcester, massachusetts * willing to share home blood pressure monitoring data * comfortable with the use of smartphones and mobile apps exclusion criteria: * severe hypertension (systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg) * current diagnosis of preeclampsia * active substance use * serious physical illness (e.g., unable to interact with a smart device) * enrolled in another home blood pressure monitoring program * excluded from study participation by their provider * inability to provide informed consent * prisoners/institutionalized individuals

Keywords: hypertension in pregnancy moms@home mobile health intervention blood pressure blood pressure management hypertension gestational hypertension storytelling home blood pressure monitoring storytelling mobile intervention
abuse potential of single doses of lorcaserin in healthy recreational polydrug users

Conditions: Drug Abuse; Healthy

Summary: the purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.


Eligibility criteria:
inclusion criteria 1. healthy male or female subjects 18 to 55 years of age, inclusive. 2. body mass index (bmi) within the range of 18 to 33 kg/m2, inclusive, and a minimum weight of at least 50 kg at screening. 3. free from any clinically significant medical or psychiatric abnormality 4. recreational polydrug user with a history of psychedelic and depressant drug use,and at least one occasion of use in the past 3 months. 5. female subjects must have a negative serum pregnancy test at screening and urine pregnancy test at each admission. 6. female subjects of childbearing potential must be practising abstinence or using and willing to continue using a medically acceptable form of birth control for at least 1 month after the last study drug administration. male subjects who have female partners of childbearing potential must ensure that their partner use an acceptable method of contraception. 7. willingness to take a drug that might alter perception in a controlled setting. exclusion criteria a subject will not be considered eligible to participate in this study, if any one of the following exclusion criteria is satisfied: 1. a history or presence of drug or alcohol dependence (excluding nicotine and caffeine). 2. use of non-prescription, prescription medication or natural health products (except acetaminophen, vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 7 days prior to first drug administration in the qualification phase and throughout the study. 3. use of ssris (e.g. fluoxetine, paroxetine, citalopram) within 14 days prior to first drug administration in the qualification phase and throughout the study. 4. history of allergy or hypersensitivity to the study drugs 5. female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration 6. treatment with any investigational drug within 30 days prior to first drug administration during the qualification phase.

Keywords: abuse potential
monster screw system post-market clinical follow-up study

Conditions: Ankle Injuries; Foot Injury

Summary: post-market clinical follow-up study on the monster screw system

ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the monster screw system.

Eligibility criteria:
inclusion criteria: * the subject has undergone a foot and/or ankle procedure using the monster screw system and completed by one of the investigators. * the subject has adequate radiographic and medical records for the prospective data collection: - the subject is willing to provide written informed consent exclusion criteria: -none
ultrathin bronchoscopy for solitary pulmonary nodules

Conditions: Lung Cancer

Summary: the evaluation of solitary pulmonary nodules (spn) requires a balance between procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is endemic. data on ultrathin bronchoscopy (ub) for this purpose is limited. in this prospective randomised trial we compared diagnostic yield and adverse events of ub with standard-size bronchoscopy (sb) in a cohort of patients with spn located beyond the visible range of sb.

the present prospective single-centre randomised pilot study was performed at tygerberg academic hospital, a tertiary university hospital in cape town, south africa, with a referral drainage area of 1.5 million people and tuberculosis notification rate of up to 1'000/100'000 persons per year when the study was performed. between november 2000 and november 2003 all patients referred to the lung unit with single pulmonary lesion ≤ 6 cm in diameter on chest computed tomography (ct) were included. spn was defined as a single and circumscribed pulmonary lesion with a diameter ≤ 6.0 cm, surrounded by aerated lung tissue, and without evidence of atelectasis, pneumonitis, or cavity on ct scan. location and maximal diameter of all spns were recorded from the chest ct prior to enrolment of patients. inclusion criteria were a previous cytological and microbiological negative sputum examination, absence of enlarged mediastinal or hilar lymph nodes on chest ct scan, and informed consent obtained before start of the procedure. exclusion criteria were spn with lesion size unchanged over two years, inability to undergo bronchoscopy or thoracotomy, and pregnancy. participants with consent for participation in the study in whom the lesion was found to be visible on sb were then not randomised and not considered part of the study population. written informed consent was obtained from all patients before inclusion in the study.

Eligibility criteria:
inclusion criteria: * pulmonary nodule on a recent ct * non-visible on standard-size bronchoscopy exclusion criteria: * missing informed consent
zenith® low profile aaa endovascular graft

Conditions: Abdominal Aortic Aneurysms; Iliac Aneurysms; Aorto-iliac Aneurysms

Summary: this extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.


Eligibility criteria:
inclusion criteria: •subject has at least one of the following * aortic or aortoiliac aneurysm * iliac aneurysm * aneurysm with a history of growth exclusion criteria: * less than 18 years of age * inability or refusal to give informed consent * life expectancy less than 2 years * pregnant of breastfeeding or planning on becoming pregnant with 60 months * unwilling to comply with the follow-up schedule

Keywords: low profile abdominal aortic aneurysms endovascular
the effects of a multi-factorial rehabilitation program for healthcare workers suffering from post-covid-19 fatigue syndrome

Conditions: COVID-19

Summary: the sars-cov2 pandemic has kept the world in suspense for over a year now. almost 100 million people around the world have contracted covid-19 to date and over 2 million people have died of covid-19 by the end of january 2021. despite the tragedy of these deaths, it must be pointed out at this point that the number of covid-19 survivors is significantly larger. these covid-19 survivors are now the focus of interest in rehabilitation measures, as it has been shown that survival of the disease does not go hand in hand with a complete cure. thirty-five percent of all covid-19 survivors and 87% of the covid-19 survivors who were hospitalized in the course of their illness suffer from after-effects that are currently summarized as post-covid fatigue syndrome also known as "long-covid". as health care workers are at higher risk of contracting sars cov2 and furthermore, considering their central role in the overcoming of this pandemic, a covid-19 rehabilitation program for healthcare workers of the medical university of vienna, austria as well as the general hospital of vienna, austria - together the second-largest university-clinic in the world - was developed as part of workplace health promotion. nowadays, the fatigue syndrome is primarily known as a side effect of cancer treatment and thus from the rehabilitation of cancer patients. cancer-related fatigue is a massive limiting side effect for patients and the currently most effective treatment strategy against cancer-associated fatigue syndrome is physical training. the idea for this current project is, that physical exercise might have similar effects on post-sars-cov2 fatigue as it has on cancer-related fatigue. the current study evaluates the effects of this primarily exercise-based rehabilitation program on long-covid fatigue.

employees of the medical university of vienna, austria and the general hospital of vienna, austria who survived a sars-cov2 infection will be invited to take part in an eight weeks post-covid-19 rehabilitation program which is part of a workplace health promotion measure. this program consists of eight weeks of exercising (twice per week supervised resistance training + individual, heart-rate controlled endurance training recommendations) with a sports scientist and a sports medicine specialist, complemented by one session of nutrition consultation with a nutritionist and two sessions of psychological consultation with a clinical psychologist. parallel to this workplace health promotion program, the scientific evaluation of this intevention will be undertaken via this study.

Eligibility criteria:
inclusion criteria: * employees of the medical university of vienna, austria or the general hospital of vienna, austria * survived covid-19 infection exclusion criteria: * acute covid-19 infection * serious, uncontrolled diseases of the cardiovascular system * insufficient language skills to complete the study requirements

Keywords: long-covid sars-cov fatigue syndrome exercise rehabilitation
negative pressure wound therapy for surgical site infection prevention in common femoral artery exposure

Conditions: Surgical Site Infection; Groin Infections

Summary: the purpose of this randomized clinical trial is to investigate the role of negative pressure wound therapy (npwt) vs standard sterile gauze therapy on the incidence of surgical site infections (ssi) in primarily closed groin incisions in high risk patients undergoing any open common femoral artery exposure for a vascular surgery procedure.

eligible patients are randomized pre-operatively into either a standard dressing or npwt for the groin incision. * 1 the control group receive a standard sterile gauge dressing over the groin incision. the dressing is removed on post-operative day #2 and the wound is inspected for a ssi or dehiscence, followed by daily dressing changes and wound inspections until discharge. * 2 the intervention group will receive a npwt dressing which will be applied in the operating room under sterile conditions. the npwt dressing will be removed on post operative day 5. the wound is inspected for a ssi or dehiscence, followed by daily dressing changes and wound inspections until discharge.

Eligibility criteria:
inclusion criteria: one or more of the following * body mass index \>30 kg/m2 * critical limb ischemia defined by ankle brachial index\<0.35, rest pain, tissue loss and/or non-healing ulcers * procedure time \>240 min * end stage renal disease on dialysis * glycated hemoglobin ≥ 8.5% * transfusion ≥ 3 units packed red blood cells * previous femoral artery cut-down exclusion criteria:any of the following * preexisting groin infection * complete vacuum seal cannot be achieved with negative pressure device * allergy to adhesive material * groin surgery within last 30 days

Keywords: negative pressure wound therapy
novel amblyopia treatment with virtual reality games

Conditions: Amblyopia

Summary: the goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. the main question it aims to answer is: is a 16-week course of amblyopia treatment using vivid vision therapeutic (dichoptic) virtual reality games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye va, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? participants will each serve as their own control and complete: treatment period 1: continued optical correction (glasses) alone for 16 weeks; treatment period 2: vivid vision therapeutic (dichoptic) virtual reality games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction


Eligibility criteria:
inclusion criteria: patients ages 5 to 17 years of age * moderate to severe unilateral amblyopia (logmar best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd * age normal va in the nonamblyopic eye * spectacle correction (if required) worn for at least 16 weeks, or until stability of va is demonstrated (\<0.1 logmar change by the same testing method measured on 2 exams at least 8 weeks apart) * interocular difference of ≥ 3 lines * no amblyopia treatment in the past 2 weeks * an interpupillary distance of 52-72 mm (inclusive) exclusion criteria: * myopia greater than -6.00 diopters (d) spherical equivalent in either eye. * previous intraocular or refractive surgery. * previous dichoptic treatment \> 2 weeks in duration * ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met). * diplopia more than once per week over the last week prior to enrollment by parental report. * down syndrome or cerebral palsy. * light-induced seizures * known simulator sickness * severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). participants with mild speech delay or reading and/or learning disabilities are not excluded.
maternal-fetal cd4 microchimerism in hiv exposed newborns after spontaneous delivery and cesarean section

Conditions: Human Immunodeficiency Virus

Summary: the aim of this single centre study is to measure maternal cd4+ t-cells in hiv exposed newborns after spontaneous birth in comparison to cesarean section. this may have an influence on the risk of vertical hiv transmission.

at birth maternal cd4+ t-cells from umbilical cord blood and placenta blood are measured by microchimerism-analysis. after 6 weeks the maternal cd4+ t-cells are measured in the blood of the babies blood. additionally we look for hiv in maternal cd4+ t-cells.

Eligibility criteria:
inclusion criteria: • hiv exposed newborns with normal risk of hiv transmission. exclusion criteria: * hiv exposed newborns wiht elevated or high risk of hiv transmission. * hiv exposed newborns of mothers not full of age. * missing informed consent of at least the mother * outborns * asphyxia * major congenital defects * chromosomal anomalies

Keywords: human immunodeficiency virus microchimerism maternal-fetal exchange gestation hiv-vertical transmission
examination of adma serum level and ddah ii

Conditions: Septic Shock; Sepsis

Summary: examination of adma (asymmetric-dimethylarginine)-serum level and ddah ii (dimethylarginine dimethylaminohydrolase)- polymorphism in patients with severe sepsis and septic shock as prognostic value. this study looks into adma as a good prognostic factor for sepsis. further more the dependency of the adma level to the ddah ii polymorphisms is reviewed this study.

secondary targets are the mortality (28 days icu), the length of hospitalisation in icu and peripheral station, the severity of the illness (saps ii score), the sofa-score values in the progress and the procalcitonin values in the progress

Eligibility criteria:
inclusion criteria: * \>18 y/o * sepsis * septical shock exclusion criteria: * primary cardiogenic shock * pregnancy * breastfeeding * non compliance * moribund status

Keywords: adma ddah ii saps sofa sepsis procalcitonin icu mortality length of stay
the ajyal salima longitudinal study to prevent childhood obesity

Conditions: Childhood Obesity

Summary: the study was carried out to determine the long-term effectiveness of a school-based intervention programme when implemented over 2 years and its sustained effect one year later.


Eligibility criteria:
inclusion criteria: schoolchildren aged 8-12 years exclusion criteria: * no exclusion criteria

Keywords: bmi health policies school health promotion intervention
a phase i/ii dose escalation study using extracranial stereotactic radiosurgery to control pain

Conditions: Metastases

Summary: this study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.

the goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma) * pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to esrt * have had prior radiation to area of spine felt to be cause of patient's pain * zubrod performance status of 0-3 * life expectancy of ≥ 3 months * signed informed consent prior to registration to study * radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging. exclusion criteria: * women who are pregnant or nursing * either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled' * no radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention) * no initiation of chemotherapy within 15 days of trial entry. * no plans for concomitant antineoplastic therapy (including standard fractionated rt, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery. * no active systemic infection. * no evidence of myelopathy or cauda equina syndrome on clinical evaluation
the efficacy and safety study of fuganlin oral liquid in children with influenza (acute upper respiratory infection)

Conditions: Acute Upper Respiratory Infection

Summary: randomized, double blind, double dummy, positive drug parallel comparison, multi-centre clinical trial to assess the efficacy and safety of fuganlin oral liquid in children with influenza (acute upper respiratory infection).

treatment group: fuganlin oral liquid 10ml. control group: xiaoer jiebiao oral liquid 100ml. treatment for one week. patients who were recovered within one week can withdrawal at any time.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as acute upper respiratory infection. 2. patients with traditional chinese medicine syndrome of qi deficiency and wind-heat. 3. patients aged 1 to 12 years. 4. with course of disease in 48 hours or less. 5. signed informed consent by a parent or legal guardians. exclusion criteria: 1. patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia; 2. patients have a history of hyperpyretic convulsion; 3. severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases; 4. the increased of serum creatinine (cr), blood urea nitrogen (bun), alanine aminotransferase (alt), and urinary protein, urine rbc above "+", which can not use the test illness or possibly combined disease conditions to explain; 5. patients with allergic physique (allergic to above two kinds of substance), allergic to the composition of the preparation or control drug; 6. according to the doctors' determination,likely to loss to follow up.

Keywords: acute upper respiratory infection
the effectiveness of photographic educational material on carbohydrate counting for adolescents with diabetes

Conditions: Diabetes Mellitus

Summary: the hypothesis of this study focuses on obtaining accurate information on the effectiveness of photographic educational material on orientation of carbohydrate counting for adolescents with diabetes.

the adolescents with diabetes at the pediatric endocrinology and diabetes outpatient clinic, will be randomly distributed between two groups: those who will receive orientation on carbohydrate counting through photographic educational material and those through a list of foods equivalent. research will follow 3 steps: first, data will be collected on age, gender, bmi, hba1c, schooling, type of educational material and parents grade level; answer sheets will be applied to evaluate previous knowledge on carbohydrate counting; orientation will be provided on counting with photo material or list. second, after a month of using the educational material, a quiz by phone will be conducted with the sole intent to reinforce orientation. third, two days later, adolescents will be directed to the experimental kitchen to see portions of real food and provide answers on amount or choice of carbohydrate. statistical tools will be applied to evaluate results.

Eligibility criteria:
inclusion criteria: * adolescents with diabetes aged 11 years to 19 years who count carbohydrates in their diet. * adolescents with more than 6 years of study . * there is no restriction ethnic, social, gender, nutrition status, type of diabetes. exclusion criteria: * adolescents with diabetes aged 11 years to 19 years who not count carbohydrate counting in your diet. * adolescents with less than 6 years of study. * adolescents who don't want to participated in this research.

Keywords: education diabetes mellitus adolescent diabetic diet